奥沙利铂联合卡培他滨一线治疗进展期胃癌的临床疗效观察

Oxaliplatin combined with capecitabine as first-line chemotherapy for patients with advanced gastric cancer

背景与目的:奥沙利铂联合卡培他滨(XELOX方案)是治疗进展期胃癌(advanced gastric cancer,AGC)的有效方案,但是该方案作为一线方案治疗AGC患者的疗效和安全性尚不确定。本研究旨在探讨XELOX方案作为一线方案治疗AGC的疗效及安全性。方法:33例既往未接受过化疗的AGC患者采用XELOX方案化疗,奥沙利铂130mg/m2,静脉滴注2h,d1;卡培他滨2000mg/m2,分2次口服,d1～14,21天为一个周期。患者最多接受8个周期化疗。结果:33例患者共接受159个周期的化疗,中位化疗周期数为5个。31例患者可评价疗效,其中完全缓解1例(3.2%),部分缓解16例(51.6%),稳定8例(25.8%),进展6例(19.4%)。客观有效率54.8%(95%可信区间37.3%～72.3%),临床获益率80.6%(95%可信区间66.7%～94.5%)。平均随访10.5个月,中位疾病进展时间5.9个月(95%可信区间4.7～7.1个月),中位生存时间10.4个月(95%可信区间7.9～12.9个月)。常见不良反应有骨髓抑制、外周神经毒性、胃肠道反应、手足综合征等,经对症治疗后均好转,无治疗相关性死亡。结论:XELOX方案一线治疗AGC疗效显著,耐受性良好。

Background and Objective. Combination therapy of oxaliplatin and capecitabine has certain effects on advanced gastric cancer （AGC）. This study was to investigate the efficacy and safety of oxaliplatin in combination with capecitabine as first-line chemotherapy for AGC patients. Methods. Thirty-three chemotherapy-naive patients with AGC were entered into this study. They received 2 h intravenous infusion of oxaliplatin 130 mg/m^2 on day 1 and oral administration of capecitabine 2000 mg/m^2, given in two daily doses, on days 1-14 （XELOX regimen）. The regimen was repeated every 21 days. A maximum of eight cycles were given. Results. Thirty-three patients completed 159 cycles of chemotherapy with a median number of five cycles. Thirty-one patients were evaluable for efficacy. The response rate was 54.8% [95% confidence interval （CI）： 37.3%-72.3% 1, with one complete response （3.2%）, 16 partial responses （51.6%）, eight stable diseases （25.8%）, and six progressions （19.4%）. At a mean follow-up of 10.5 months, the median time to progression and overall survival were 5.9 （95% CI. 4.7- T.1） and 10.4 months （95% CI： 7.9-12.9）, respectively. The most common adverse events were myelosuppression, peripheral neuropathy, diarrhea, nausea/vomiting, and hand-foot syndrome. Conclusion. XELOX is an effective and well-tolerated first-line chemotherapy regimen for patients with AGC.